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Gilteritinib Side Effects

Medically reviewed by Last updated on Jun 15, 2023.

Applies to gilteritinib: oral tablet.


Oral route (Tablet)

Warning: Differentiation SyndromePatients treated with gilteritinib have experienced symptoms of differentiation syndrome, which can be fatal or life-threatening if not treated. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, or renal dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.

Serious side effects of Gilteritinib

Along with its needed effects, gilteritinib may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking gilteritinib:

More common

Less common

Other side effects of Gilteritinib

Some side effects of gilteritinib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

For Healthcare Professionals

Applies to gilteritinib: oral tablet.


Common (1% to 10%): Anaphylactic reaction[Ref]


Very common (10% or more): Pneumonia (15%), sepsis (15%)[Ref]


Very common (10% or more): Myalgia/arthralgia (e.g., arthralgia, back pain, bone pain, myalgia, musculoskeletal pain, neck pain, non-cardiac chest pain, pain in extremity) (42%)[Ref]


Very common (10% or more): Hyperglycemia (86%), hypocalcemia (61%), edema (34%), hyponatremia (32%), decreased appetite (15%)[Ref]


Very common (10% or more): Insomnia (14%)[Ref]


Very common (10% or more): Increased transaminases (aspartate aminotransferase increased, alanine aminotransferase increased, transaminases increased, liver function test increased, hepatic failure, hepatocellular injury, hepatotoxicity) (41%), bilirubin increased (11%)[Ref]


Very common (10% or more): Dyspnea (34%), pneumonia (30%), cough (25%)[Ref]


Very common (10% or more): Fatigue/malaise (40%), fever (35%)

Common (1% to 10%): Differentiation syndrome[Ref]

Nervous system

Very common (10% or more): Headache (21%), dizziness (20%), dysgeusia (11%)

Common (1% to 10%): Posterior reversible encephalopathy syndrome (PRES)[Ref]


Very common (10% or more): Renal impairment (e.g., acute kidney injury, blood creatinine increased, chronic kidney disease, oliguria, renal disorder, renal

failure, renal impairment, renal injury, renal tubular necrosis) (19%)[Ref]


Very common (10% or more): Hypotension (30%), hypertension (10%)

Common (1% to 10%): Prolonged QT interval, cardiac failure (e.g., cardiac failure, cardiac failure congestive, cardiomyopathy, cardiomegaly, chronic left ventricular failure, ejection fraction decreased), pericardial effusion, pericarditis[Ref]


Very common (10% or more): Rash (30%)[Ref]


Very common (10% or more): Noninfectious diarrhea (34%), nausea (27%), stomatitis (26%), vomiting (20%), abdominal pain (e.g., abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, epigastric discomfort, GI pain) (17%)[Ref]

Frequently asked questions


1. (2018) "Product Information. Xospata (gilteritinib)." Astellas Pharma US, Inc

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.